Closed suction system

ABSTRACT

A cleaning catheter insertable into a ventilation tube and an input module are provided, the input module coupled to the cleaning catheter and including (i) an inflation module, including an inflation chamber and a one-way air inlet valve; (ii) a flow regulator operable to assume first and second fluid-control states; and (iii) a mechanical user control element operable (a) to mechanically and non-electrically set the fluid-control states, (b) to assume first and second configurations, and (c) to mechanically and non-electrically increase pressure in an interior of an inflation chamber of the cleaning catheter during a transition of the mechanical user control element from the first configuration to the second configuration. The one-way air inlet valve is arranged to allow air to flow into the inflation chamber during a transition of the mechanical user control element from the second configuration to the first configuration.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. Patent applicationSer. No. 15/363,782, filed Nov. 29, 2016, which claims the benefit ofU.S. Provisional Application 62/287,223, filed Jan. 26, 2016, and U.S.Provisional Application 62/319,640, filed Apr. 7, 2016, and which claimsforeign priority from UK Application 1600233.9, filed Jan. 6, 2016, allof which are incorporated herein by reference in their entirety.

FIELD OF THE APPLICATION

The present invention relates generally to medical suction catheterdevices, and specifically to catheter devices for aspiration oftracheobronchial secretions and/or cleaning of tracheal ventilationtubes.

BACKGROUND OF THE APPLICATION

Suction catheters are commonly used to aspirate tracheobronchial fluidsin patients ventilated with endotracheal tube (ETT) and tracheostomytube devices. A problematic aspect of the use of suction catheters isthe presence of bacterial biofilm within the ETT lumen through which thesuction catheter passes. Consequently, as the suction catheter isinserted, there is high risk of it carrying bacterial biofilm from theETT lumen deeper into the bronchial tree where the suction catheterreaches, and thereby increasing the risk of lung infection. Moreover,buildup of substantial biofilm thickness reduces the effective freelumen of the ETT for air passage. Therefore, there is a need formaintaining cleaner ETT lumens between suction operations, andpreventing buildup of significant biofilm thickness.

UK Publication GB 2482618 A to Einav et al., which is assigned to theassignee of the present application and is incorporated herein byreference, describes a multi-lumen catheter for multiple fluidsconduction, including balloon inflation with air via an inflation lumen,suction via a suction lumen, and cleaning fluids delivery via a cleaningfluid-delivery lumen.

U.S. Pat. No. 8,999,074 to Zachar et al., which is assigned to theassignee of the present application and is incorporated herein byreference, describes a cleaning catheter that includes fluid-deliveryand suction lumens. A flow regulator defines suction and fluid ports. Amechanical user control element is configured to mechanically andnon-electrically set activation states of the flow regulator, andtransition between first and third configurations via a secondconfiguration. When the control element is in the first configuration,the flow regulator blocks fluid communication (a) between the suctionport and the suction lumen and (b) between the fluid port and thefluid-delivery lumen. When the control element is in the secondconfiguration, the flow regulator effects fluid communication betweenthe suction port and the suction lumen, and blocks fluid communicationbetween the fluid port and the fluid-delivery lumen. When the controlelement is in the third configuration, the flow regulator effects fluidcommunication (a) between the suction port and the suction lumen and (b)between the fluid port and the fluid-delivery lumen.

SUMMARY OF THE APPLICATION

Some applications of the present invention provide a multi-lumencatheter for cleaning an inner surface of a tracheal ventilation tube.Some techniques of the present invention enable single-handedsimultaneous activation of inflation of an inflatable element andsuctioning in a closed suction system for use with the trachealventilation tube. A closed suction system allows catheters to be usedrepeatedly without being detached from the tube system including theventilation air supply. Applications of the present invention generallyprovide simple user control of conduction of fluids under positive andnegative pressure (suction).

The cleaning catheter is insertable into the tracheal ventilation tube,and is shaped so as to define one or more distal suction orifices. Thecleaning catheter comprises an elongate, flexible, tubular catheter mainbody, and an inflatable element, which is mounted to the catheter mainbody, typically at a location within 3 cm of at least one of the one ormore distal suction orifices. An input module is coupled to the cleaningcatheter, and comprises an inflation module, which comprises aninflation chamber separate from the suction source. The input modulealso comprises a flow regulator, which (a) is shaped so as to define asuction port coupleable in fluid communication with the suction source,and (b) is configured to assume at least first and second fluid-controlstates.

The input module further comprises a mechanical user control element,which is configured (a) to mechanically and non-electrically set thefluid-control states of the flow regulator, (b) to assume at least firstand second configurations, and (c) to mechanically and non-electricallyincrease pressure in an interior of the inflation chamber during atleast a portion of a transition of the mechanical user control elementfrom the first configuration to the second configuration. The inputmodule is arranged such that:

-   -   when the mechanical user control element is in the first        configuration, the flow regulator is in the first fluid-control        state, in which the flow regulator blocks fluid communication        between the suction source and the distal suction orifices, and    -   when the mechanical user control element is in the second        configuration, the flow regulator is in the second fluid-control        state, in which the flow regulator (A) connects the suction        source and the distal suction orifices in fluid communication,        and (B) connects the interior of the inflation chamber and an        interior of the inflatable element in fluid communication to        inflate the inflatable element.

As a result of this arrangement, a single mechanical user controlelement both (a) mechanically creates pressure to inflate the inflationelement and (b) mechanically connects the suction source and the distalsuction orifices in fluid communication.

In some applications of the present invention, the input module isarranged such that:

-   -   when the mechanical user control element is in the first        configuration and the flow regulator is in the first        fluid-control state, the flow regulator connects the suction        source and the interior of the inflatable element in fluid        communication to deflate the inflatable element, and    -   when the mechanical user control element is in the second        configuration and the flow regulator is in the second        fluid-control state, the flow regulator does not connect the        suction source and the interior of the inflatable element in        fluid communication.

In some applications of the present invention, the fluid-control statesare actuated by axial motion of a proximal portion of the catheter mainbody relative to an input module housing. For some of theseapplications, transitions between the states are caused by shifts inalignment of lumen inlets with respect to various chambers of the inputmodule. The shifts in alignment are typically caused via axial motion ofa proximal-most input portion of the catheter main body within the inputmodule housing, along the longitudinal axes of the input portion and theinput module. For some applications, the mechanical user control elementcomprises a user control handle, the movement of which includes acomponent perpendicular to the associated axial motion of the cathetermain body. The mechanical user control element translates the movementof the user control handle into axial motion of the catheter main bodywith respect to the input module housing.

In other applications of the present invention, the fluid-control statesare not actuated by axial motion of the proximal portion of the cathetermain body relative to the input module housing, and the mechanical usercontrol element does not translate the movement of the user controlhandle into axial motion of the catheter main body relative to the inputmodule housing. Instead, the proximal-most input portion of the cathetermain body is fixed with respect to the input module. The movement of theuser control handle actuates the fluid-control states withouttranslating the movement into axial motion of the proximal portion ofthe catheter main body. The input module is arranged such that the usercontrol handle is moveable with respect to the catheter main body in twoopposite directions along a movement axis that forms a fixed angle ofbetween 45 and 135 degrees with a central longitudinal axis of theproximal-most input portion of the catheter main body, typically 90degrees. The input module is arranged such that movement of the usercontrol handle along the movement axis mechanically causes correspondingmovement, along or alongside the movement axis, of a distal opening ofthe suction port, which selectively brings the distal end of the suctionport into and out of fluid communication with the interior of theinflatable element and the distal suction orifices.

For some applications, the inflation chamber is disposed within themechanical user control element; for example, the inflation chamber maybe defined by one or more interior surfaces of the user control handle.

In other applications of the present invention, the input module isarranged such that when the mechanical user control element is in thefirst configuration and the flow regulator is in the first fluid-controlstate, the flow regulator connects the interior of the inflation chamberand the interior of the inflatable element in fluid communication todeflate the inflatable element.

For cleaning a ventilation tube, the cleaning action typically comprisesthe following steps, which are typically performed in the followingorder:

-   -   inserting the cleaning catheter into the ventilation tube in a        proximal to distal direction while the inflatable element (e.g.,        balloon) is essentially deflated;    -   inflating the inflatable element at a location near the distal        end of the ventilation tube (typically within 2 cm of the distal        end);    -   withdrawing the catheter along the ventilation tube in a distal        to proximal direction while the inflatable element is inflated        and suction is applied to the one or more suction orifices; and    -   deflating the inflatable element when the inflatable element is        near the proximal end of the ventilation tube or fully outside        the proximal end of the ventilation tube.

There is therefore provided, in accordance with an application of thepresent invention, apparatus for use with a tracheal ventilation tubeand a suction source, the apparatus including:

(A) a cleaning catheter, which (a) is insertable into the ventilationtube, (b) is shaped so as to define one or more distal suction orifices,and (c) which includes:

-   -   (i) an elongate, flexible, tubular catheter main body; and    -   (ii) an inflatable element, which is mounted to the catheter        main body at a location within 3 cm of at least one of the one        or more distal suction orifices; and

(B) an input module, which is coupled to the cleaning catheter, andincludes:

-   -   (i) an inflation module, which includes (a) an inflation chamber        separate from the suction source, and (b) a one-way air inlet        valve;    -   (ii) a flow regulator, which (a) is shaped so as to define a        suction port coupleable in fluid communication with the suction        source, and (b) is configured to assume at least first and        second fluid-control states; and    -   (iii) a mechanical user control element, which is configured (a)        to mechanically and non-electrically set the fluid-control        states of the flow regulator, (b) to assume at least first and        second configurations, and (c) to mechanically and        non-electrically increase pressure in an interior of the        inflation chamber during at least a portion of a transition of        the mechanical user control element from the first configuration        to the second configuration,

wherein the input module is arranged such that:

-   -   at least when the mechanical user control element is in the        first configuration, the flow regulator is in the first        fluid-control state, in which the flow regulator (a) blocks        fluid communication between the suction source and the distal        suction orifices and (b) connects the suction source and an        interior of the inflatable element in fluid communication to        deflate the inflatable element,    -   at least when the mechanical user control element is in the        second configuration, the flow regulator is in the second        fluid-control state, in which the flow regulator (a) connects        the suction source and the distal suction orifices in fluid        communication, (b) connects the interior of the inflation        chamber and an interior of the inflatable element in fluid        communication to inflate the inflatable element, and (c) does        not connect the suction source and the interior of the        inflatable element in fluid communication, and    -   the flow regulator is (a) not in the first fluid-control state        when the mechanical user control element is in the second        configuration, and (b) not in the second fluid-control state        when the mechanical user control element is in the first        configuration,    -   wherein the one-way air inlet valve is arranged to allow air to        flow into the inflation chamber during at least a portion of a        transition of the mechanical user control element from the        second configuration to the first configuration.

For some applications, the mechanical user control element is configuredto mechanically and non-electrically increase the pressure in theinterior of the inflation chamber during an entirely of the transitionof the mechanical user control element from the first configuration tothe second configuration.

For some applications, the input module is configured such that duringthe at least a portion of the transition of the mechanical user controlelement from the first configuration to the second configuration, beforethe flow regulator assumes the second fluid-control state, a volume ofthe interior of the inflation chamber decreases by between 10% and 90%.

For some applications, the mechanical user control element is configuredto mechanically and non-electrically increase the pressure in theinterior of the inflation chamber during motion of the mechanical usercontrol element while the flow regulator is in the second fluid-controlstate.

For some applications, the suction port is coupled in fluidcommunication with the suction source.

For some applications, the input module further includes a user signalgenerator, which is configured to generate a user signal during or upondeflation of the inflatable element.

For some applications, the inflation chamber has a volume of between 1and 10 cc when the mechanical user control element is in the firstconfiguration.

For some applications, when the mechanical user control element is inthe second configuration, the inflation chamber has a volume of at least1 cc less than when the mechanical user control element is in the firstconfiguration.

For some applications, the mechanical user control element is biasedtoward the first configuration.

For some applications, the cleaning catheter further includes one ormore suction lumens arranged along the catheter main body, and the flowregulator, when in the second fluid-control state, connects in fluidcommunication the suction source and the distal suction orifices via theone or more suction lumens.

For some applications, the inflatable element includes a balloon.

For some applications, the inflatable element is mounted to the cathetermain body is within 5 cm of a distal end of the catheter main body.

For some applications, the inflatable element has a greatest outerdiameter of between 6 and 12 mm when inflated at 1 bar above atmosphericpressure and unconstrained.

For some applications, the apparatus is for use with a ventilator, andthe apparatus further includes a tube-connector assembly, which isconfigured to couple the ventilation tube in fluid communication withthe ventilator, in a substantially air-tight manner.

For some applications, the first and the second configurations are firstand second spatial positions, respectively, and the mechanical usercontrol element is configured to assume at least the first and thesecond spatial positions.

For some applications, the mechanical user control element is arrangedto move between first and second spatial end-points, and the first andthe second spatial positions correspond with the first and the secondspatial end-points, respectively.

For some applications:

-   -   the flow regulator is configured to assume a third, intermediate        fluid-control state, between the first and the second        fluid-control states, in which (a) the suction source and the        distal suction orifices are in fluid communication with one        another, and (b) the interior of the inflation chamber and the        interior of the inflatable element are not in fluid        communication with one another, and    -   the flow regulator is configured to assume the third,        intermediate fluid-control state when the mechanical user        control element is in a third, intermediate configuration        between the first configuration and the second configuration.

For some applications, the one-way air inlet valve is configured togenerate a sound signal during at least a portion of a period of fluidflow into the inflation chamber.

For any of the applications described hereinabove, the mechanical usercontrol element may be configured to increase the pressure in theinterior of the inflation chamber by mechanically and non-electricallycompressing the inflation chamber during the at least a portion of thetransition of the mechanical user control element from the firstconfiguration to the second configuration.

For some applications, the inflation chamber transitions from a lowerlevel of compression to a higher level of compression during the atleast a portion of the transition of the mechanical user control elementfrom the first configuration to the second configuration, and the inputmodule is configured to elastically bias the inflation chamber towardthe lower level of compression.

For some applications, the inflation module is elastically biased towardthe lower level of compression.

For some applications, at least one wall of the inflation chamber iselastically biased toward the lower level of compression.

For some applications, the at least one wall of the inflation chamber isaccordion-shaped.

For some applications, the inflation module includes an elastic elementthat is arranged to bias the inflation chamber toward the lower level ofcompression.

For some applications, the mechanical user control element iselastically biased toward the lower level of compression.

For any of the applications described hereinabove, the catheter mainbody may include a proximal-most input portion, which is disposed withinand axially slidable with respect to the input module.

For some applications, the input module is arranged such that changes inconfiguration of the mechanical user control element cause correspondingchanges in axial position of the input portion of the catheter main bodywith respect to the input module.

For some applications, the input module is arranged such that the inputportion assumes first and second axial positions with respect to theinput module, corresponding to the first and the second configurationsof the mechanical user control element.

For any of the applications described hereinabove, the catheter mainbody may include a proximal-most input portion, which is disposed withinand fixed with respect to the input module.

For some applications:

the mechanical user control element includes a user control handle,

the input module is arranged such that the user control handle ismoveable with respect to the catheter main body in two oppositedirections along a movement axis that forms a fixed angle of between 45and 135 degrees with a central longitudinal axis of the proximal-mostinput portion of the catheter main body, and

the input module is arranged such that movement of the user controlhandle along the movement axis mechanically causes correspondingmovement, along or alongside the movement axis, of a distal opening ofthe suction port, which selectively brings the distal end of the suctionport into and out of fluid communication with the interior of theinflatable element and the distal suction orifices.

For some applications:

the inflation chamber is shaped so as to define an outlet, and

the input module is arranged such that movement of the user controlhandle along the movement axis mechanically causes correspondingmovement of the outlet of the inflation chamber along or alongside themovement axis, which selectively brings the interior of the inflationchamber into and out of fluid communication with the interior of theinflatable element.

For any of the applications described hereinabove, the inflation chambermay be disposed within the mechanical user control element.

For some applications, the mechanical user control element includes auser control handle, and the inflation chamber is defined by one or moreinterior surfaces of the user control handle.

For some applications, the input module includes exactly one mechanicaluser control element configured (a) to mechanically and non-electricallyset the fluid-control states of the flow regulator, (b) to assume the atleast first and second configurations, and (c) to mechanically andnon-electrically increase the pressure in the interior of the inflationchamber during the at least a portion of the transition of themechanical user control element from the first configuration to thesecond configuration.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with a tracheal ventilation tubeand a suction source, the apparatus including:

(A) a cleaning catheter, which (a) is insertable into the ventilationtube, (b) is shaped so as to define one or more distal suction orifices,and (c) which includes:

-   -   (i) an elongate, flexible, tubular catheter main body, which        includes a proximal-most input portion; and    -   (ii) an inflatable element, which is mounted to the catheter        main body at a location within 3 cm of at least one of the one        or more distal suction orifices; and

(B) an input module, which is fixed to the proximal-most input portionof the catheter main body of the cleaning catheter, and includes:

-   -   (i) a flow regulator, which (a) is shaped so as to define a        suction port coupleable in fluid communication with the suction        source, and (b) is configured to assume at least first and        second fluid-control states; and    -   (ii) a mechanical user control element, which includes a user        control handle, and which is configured (a) to mechanically and        non-electrically set the fluid-control states of the flow        regulator, and (b) to assume at least first and second spatial        positions,

wherein the input module is arranged such that:

-   -   the user control handle is moveable with respect to the catheter        main body in two opposite directions along a movement axis that        forms a fixed angle of between 45 and 135 degrees with a central        longitudinal axis of the proximal-most input portion of the        catheter main body, and    -   movement of the user control handle along the movement axis        mechanically causes corresponding movement, along or alongside        the movement axis, of a distal end of the suction port, which        selectively brings the distal end of the suction port into and        out of fluid communication with an interior of the inflatable        element and the distal suction orifices.

For some applications, the suction port is coupled in fluidcommunication with the suction source.

For some applications, the mechanical user control element is biasedtoward the first spatial positions.

For some applications, the inflatable element includes a balloon.

For any of the applications described hereinabove:

the input module may further include an inflation module, which includesan inflation chamber separate from the suction source, and

the mechanical user control element may be configured to mechanicallyand non-electrically increase pressure in an interior of the inflationchamber during at least a portion of a transition of the mechanical usercontrol element from the first spatial position to the second spatialposition.

For some applications, the inflation chamber is disposed within themechanical user control element.

For some applications, the inflation chamber is defined by one or moreinterior surfaces of the user control handle.

For some applications:

the inflation chamber is shaped so as to define an outlet, and

the input module is arranged such that movement of the user controlhandle along the movement axis mechanically causes correspondingmovement of the outlet of the inflation chamber along or alongside themovement axis, which selectively brings the interior of the inflationchamber into and out of fluid communication with the interior of theinflatable element.

For some applications, the input module is arranged such that:

when the mechanical user control element is in the first spatialposition, the flow regulator is in the first fluid-control state, inwhich the flow regulator blocks fluid communication between the suctionsource and the distal suction orifices, and

when the mechanical user control element is in the second spatialposition, the flow regulator is in the second fluid-control state, inwhich the flow regulator (A) connects the suction source and the distalsuction orifices in fluid communication, and (B) connects the interiorof the inflation chamber and an interior of the inflatable element influid communication to inflate the inflatable element.

For some applications:

the flow regulator is configured to assume a third, intermediatefluid-control state, between the first and the second fluid-controlstates, in which (a) the suction source and the distal suction orificesare in fluid communication with one another, and (b) the interior of theinflation chamber and the interior of the inflatable element are not influid communication with one another, and

the flow regulator is configured to assume the third, intermediatefluid-control state when the mechanical user control element is in athird, intermediate spatial position between the first configuration andthe second configuration.

For some applications, the input module is arranged such that:

when the mechanical user control element is in the first spatialposition and the flow regulator is in the first fluid-control state, theflow regulator connects the suction source and the interior of theinflatable element in fluid communication to deflate the inflatableelement, and

when the mechanical user control element is in the second spatialposition and the flow regulator is in the second fluid-control state,the flow regulator does not connect the suction source and the interiorof the inflatable element in fluid communication.

For some applications, the inflation module includes a one-way air inletvalve, which is arranged to allow air to flow into the inflation chamberduring at least a portion of a transition of the mechanical user controlelement from the second spatial position to the first spatial position.

For some applications, the one-way air inlet valve is configured togenerate a sound signal during at least a portion of a period of fluidflow into the inflation chamber.

For some applications, the input module is arranged such that when themechanical user control element is in the first spatial position and theflow regulator is in the first fluid-control state, the flow regulatorconnects the interior of the inflation chamber and the interior of theinflatable element in fluid communication to deflate the inflatableelement.

For some applications, the mechanical user control element is configuredto increase the pressure in the interior of the inflation chamber bymechanically and non-electrically compressing the inflation chamberduring the at least a portion of the transition of the mechanical usercontrol element from the first spatial position to the second spatialposition.

For some applications, the inflation chamber transitions from a lowerlevel of compression to a higher level of compression during the atleast a portion of the transition of the mechanical user control elementfrom the first spatial position to the second spatial position, and theinput module is configured to elastically bias the inflation chambertoward the lower level of compression.

For some applications, the inflation module is elastically biased towardthe lower level of compression.

For some applications, at least one wall of the inflation chamber iselastically biased toward the lower level of compression.

For some applications, the at least one wall of the inflation chamber isaccordion-shaped.

For some applications, the inflation module includes an elastic elementthat is arranged to bias the inflation chamber toward the lower level ofcompression.

For some applications, the mechanical user control element iselastically biased toward the lower level of compression.

There is still further provided, in accordance with an application ofthe present invention, apparatus for use with a tracheal ventilationtube and a suction source, the apparatus including:

(A) a cleaning catheter, which (a) is insertable into the ventilationtube, (b) is shaped so as to define one or more distal suction orifices,and (c) which includes:

-   -   (i) an elongate, flexible, tubular catheter main body; and    -   (ii) an inflatable element, which is mounted to the catheter        main body at a location within 3 cm of at least one of the one        or more distal suction orifices; and

(B) an input module, which is coupled to the cleaning catheter, andincludes:

-   -   (i) a flow regulator, which (a) is shaped so as to define a        suction port coupleable in fluid communication with the suction        source, and (b) is configured to assume at least first and        second fluid-control states;    -   (ii) an inflation module, which includes an inflation chamber        separate from the suction source; and    -   (iii) a mechanical user control element, within which the        inflation chamber is disposed, and which is configured (a) to        mechanically and non-electrically set the fluid-control states        of the flow regulator, (b) to assume at least first and second        configurations, and (c) to mechanically and non-electrically        increase pressure in an interior of the inflation chamber during        at least a portion of a transition of the mechanical user        control element from the first configuration to the second        configuration.

For some applications, the mechanical user control element includes auser control handle, and the inflation chamber is defined by one or moreinterior surfaces of the user control handle.

For some applications, the input module is arranged such that:

when the mechanical user control element is in the first configuration,the flow regulator is in the first fluid-control state, in which theflow regulator blocks fluid communication between the suction source andthe distal suction orifices, and

when the mechanical user control element is in the second configuration,the flow regulator is in the second fluid-control state, in which theflow regulator (A) connects the suction source and the distal suctionorifices in fluid communication, and (B) connects the interior of theinflation chamber and an interior of the inflatable element in fluidcommunication to inflate the inflatable element.

For some applications, the suction port is coupled in fluidcommunication with the suction source.

For any of the applications described hereinabove, the catheter mainbody may include a proximal-most input portion, which is disposed withinand fixed with respect to the input module.

For some applications:

the mechanical user control element includes a user control handle,

the input module is arranged such that the user control handle ismoveable with respect to the catheter main body in two oppositedirections along a movement axis that forms a fixed angle of between 45and 135 degrees with a central longitudinal axis of the proximal-mostinput portion of the catheter main body, and

the input module is arranged such that movement of the user controlhandle along the movement axis mechanically causes correspondingmovement, along or alongside the movement axis, of a distal end of thesuction port, which selectively brings the distal end of the suctionport into and out of fluid communication with the interior of theinflatable element and the distal suction orifices.

For some applications:

the inflation chamber is shaped so as to define an outlet, and

the input module is arranged such that movement of the user controlhandle along the movement axis mechanically causes correspondingmovement of the outlet of the inflation chamber along or alongside themovement axis, which selectively brings the interior of the inflationchamber into and out of fluid communication with the interior of theinflatable element.

There is additionally provided, in accordance with an application of thepresent invention, apparatus for use with a tracheal ventilation tubeand a suction source, the apparatus including:

(A) a cleaning catheter, which (a) is insertable into the ventilationtube, (b) is shaped so as to define one or more distal suction orifices,and (c) which includes:

-   -   (i) an elongate, flexible, tubular catheter main body; and    -   (ii) an inflatable element, which is mounted to the catheter        main body at a location within 3 cm of at least one of the one        or more distal suction orifices; and

(B) an input module, which is coupled to the cleaning catheter, andincludes:

-   -   (i) an inflation module, which includes an inflation chamber        separate from the suction source;    -   (ii) a flow regulator, which (a) is shaped so as to define a        suction port coupleable in fluid communication with the suction        source, and (b) is configured to assume at least first and        second fluid-control states;    -   (iii) a first mechanical user control button, which is        configured to (a) assume at least first and second        configurations, and (b) mechanically and non-electrically set        the fluid-control states of the flow regulator;    -   (iv) a second mechanical user control button, which is        configured to (a) to assume at least first and second        configurations, and (b) mechanically and non-electrically        increase pressure in an interior of the inflation chamber during        a transition of the second mechanical user control button from        its first configuration to its second configuration,

wherein the input module is arranged such that:

-   -   at least when the first mechanical user control button is in its        first configuration, the flow regulator is in the first        fluid-control state, in which the flow regulator (a) blocks        fluid communication between the suction source and the distal        suction orifices and (b) connects the suction source and an        interior of the inflatable element in fluid communication to        deflate the inflatable element,    -   at least when the first mechanical user control button is in its        second configuration, the flow regulator is in the second        fluid-control state, in which the flow regulator (a) connects        the suction source and the distal suction orifices in fluid        communication, and (b) connects the interior of the inflation        chamber and an interior of the inflatable element in fluid        communication to inflate the inflatable element, and    -   the flow regulator is (a) not in the first fluid-control state        when the first mechanical user control button is in its second        configuration, and (b) not in the second fluid-control state        when the first mechanical user control button is in its first        configuration.

For some applications, the first and the second mechanical user controlbuttons are arranged such that a portion of one of the first and thesecond mechanical user control buttons at least partially surrounds theother of the first and the second mechanical user control buttons.

For some applications, the first and the second mechanical user controlbuttons are arranged such that a closest distance between the first andthe second mechanical user control buttons is between 0.1 mm and 2 mm.

For some applications, the input module is configured such that duringthe at least a portion of the transition of the first mechanical usercontrol button from its first configuration to its second configuration,before the flow regulator assumes the second fluid-control state, avolume of the interior of the inflation chamber decreases by between 10%and 90%.

For some applications, the second mechanical user control button isconfigured to mechanically and non-electrically increase the pressure inthe interior of the inflation chamber during motion of the secondmechanical user control button while the flow regulator is in the secondfluid-control state.

For some applications, the suction port is coupled in fluidcommunication with the suction source.

For some applications, the input module further includes a user signalgenerator, which is configured to generate a user signal during or upondeflation of the inflatable element.

For some applications, the inflation chamber has a volume of between 1and 10 cc when the mechanical user control element is in the firstconfiguration.

For some applications, when the second mechanical user control button isin the second configuration, the inflation chamber has a volume of atleast 1 cc less than when the second mechanical user control button isin the first configuration.

For some applications, the first mechanical user control button isbiased toward its first configuration.

For some applications, the second mechanical user control button isbiased toward its first configuration.

For some applications, the first and the second configurations of thefirst mechanical user control button are first and second spatialpositions, respectively, and the first mechanical user control button isconfigured to assume at least the first and the second spatialpositions.

For some applications, the first and the second configurations of thesecond mechanical user control button are first and second spatialpositions, respectively, and the second mechanical user control buttonis configured to assume at least the first and the second spatialpositions.

For some applications:

the flow regulator is configured to assume a third, intermediatefluid-control state, between the first and the second fluid-controlstates, in which (a) the suction source and the distal suction orificesare in fluid communication with one another, and (b) the interior of theinflation chamber and the interior of the inflatable element are not influid communication with one another, and

the flow regulator is configured to assume the third, intermediatefluid-control state when the first mechanical user control button is ina third, intermediate configuration between its first configuration andits second configuration.

For any of the applications described hereinabove, the inflation modulemay include a one-way air inlet valve, which is arranged to allow air toflow into the inflation chamber during at least a portion of atransition of the second mechanical user control button from its secondconfiguration to its first configuration.

For some applications, the one-way air inlet valve is configured togenerate a sound signal during at least a portion of a period of fluidflow into the inflation chamber.

For any of the applications described hereinabove, the second mechanicaluser control button may be configured to increase the pressure in theinterior of the inflation chamber by mechanically and non-electricallycompressing the inflation chamber during the at least a portion of thetransition of the second mechanical user control button from its firstconfiguration to its second configuration.

For some applications, the inflation chamber transitions from a lowerlevel of compression to a higher level of compression during the atleast a portion of the transition of the second mechanical user controlbutton from its first configuration to its second configuration, and theinput module is configured to elastically bias the inflation chambertoward the lower level of compression.

For some applications, the inflation module is elastically biased towardthe lower level of compression.

For some applications, at least one wall of the inflation chamber iselastically biased toward the lower level of compression.

For some applications, the at least one wall of the inflation chamber isaccordion-shaped.

For some applications, the inflation module includes an elastic elementthat is arranged to bias the inflation chamber toward the lower level ofcompression.

For some applications, the second mechanical user control button iselastically biased toward the lower level of compression.

There is further provided, in accordance with an application of thepresent invention, a method for use with a tracheal ventilation tube anda suction source, the method including:

coupling, in fluid communication with the suction source, a suction portof a flow regulator of an input module that (a) is configured to assumeat least first and second fluid-control states, and (b) includes (i) aninflation module, which includes an inflation chamber separate from thesuction source, and (ii) a mechanical user control element, which isconfigured to mechanically and non-electrically set the fluid-controlstates of the flow regulator;

setting the mechanical user control element in a first configuration, inwhich the flow regulator is in a first fluid-control state, in which theflow regulator blocks fluid communication between the suction source andone or more distal suction orifices defined by a cleaning catheter that(a) is coupled to the input module and (b) includes (i) an elongate,flexible, tubular catheter main body, and (ii) an inflatable element,which is mounted to the catheter main body at a location within 3 cm ofat least one of the one or more distal suction orifices, wherein atleast when the mechanical user control element is in the firstconfiguration, the flow regulator is in the first fluid-control state,in which the flow regulator connects the suction source and an interiorof the inflatable element in fluid communication to deflate theinflatable element;

while the mechanical user control element is in the first configuration,inserting the cleaning catheter, in a proximal to distal direction, intothe ventilation tube inserted in a trachea of a patient, and advancingthe cleaning catheter until a distal end of the catheter main body isaxially disposed in the ventilation tube at a location more distal thanan axial mid-point of the ventilation tube; and

while the cleaning catheter is thus disposed, transitioning themechanical user control element from the first configuration to a secondconfiguration, in which the flow regulator is in a second fluid-controlstate, in which the flow regulator (a) connects the suction source andthe distal suction orifices in fluid communication, and (b) connects aninterior of the inflation chamber and an interior of the inflatableelement in fluid communication to inflate the inflatable element,

wherein the mechanical user control element is configured tomechanically and non-electrically increase pressure in an interior ofthe inflation chamber during at least a portion of the transitioning ofthe mechanical user control element from the first configuration to thesecond configuration.

For some applications, the input module is configured such that duringthe at least a portion of the transition of the mechanical user controlelement from the first configuration to the second configuration, beforethe flow regulator assumes the second fluid-control state, a volume ofthe interior of the inflation chamber decreases by between 10% and 90%.

For some applications, the inflation chamber includes a one-way airinlet valve, which is arranged to allow air to flow into the inflationchamber during at least a portion of a transition of the mechanical usercontrol element from the second configuration to the firstconfiguration.

The present invention will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a closed suction cleaning system,in accordance with an application of the present invention;

FIG. 2 is another schematic illustration of the closed suction cleaningsystem of FIG. 1, in accordance with an application of the presentinvention;

FIG. 3 is a schematic illustration of a catheter main body of the closedsuction cleaning system of FIGS. 1 and 2, and more particularly is aschematic cross-sectional illustration taken along line Z-Z of FIG. 2,in accordance with an application of the present invention;

FIG. 4 is a schematic cross-sectional illustration of a closed suctioncleaning system in a first fluid-control state, and more particularly isa schematic cross-sectional illustration taken along line Z-Z of FIG. 2,in accordance with an application of the present invention;

FIGS. 5A-C are schematic cross-sectional illustrations of a portion ofthe closed suction cleaning system of FIG. 4 in the first fluid-controlstate, a second fluid-control state, and a third fluid-control state,respectively, in accordance with an application of the presentinvention;

FIGS. 6A-C are schematic cross-sectional illustrations of another closedsuction cleaning system in a first fluid-control state, a thirdintermediate fluid-control state, and a second fluid-control state,respectively, in accordance with an application of the presentinvention;

FIG. 7 is another schematic cross-sectional illustration of the closedsuction cleaning system of FIGS. 6A-C in the first fluid-control state,in accordance with an application of the present invention;

FIGS. 8 and 9 are schematic cross-sectional illustrations of yet anotherclosed suction cleaning system in first and second fluid-control states,respectively, in accordance with an application of the presentinvention;

FIG. 10 is a schematic cross-sectional illustration of another closedsuction cleaning system in a first fluid-control state, in accordancewith an application of the present invention; and

FIGS. 11A-C are schematic cross-sectional illustrations of a portion ofthe closed suction cleaning system of FIG. 10 in the first fluid-controlstate, a second fluid-control state, and a third fluid-control state,respectively, in accordance with an application of the presentinvention.

DETAILED DESCRIPTION OF APPLICATIONS

FIGS. 1 and 2 are schematic illustrations of a closed suction cleaningsystem 100, in accordance with an application of the present invention.Cleaning system 100 is configured for use with a tracheal ventilationtube 160, a ventilator 170, and a suction source 601. For someapplications, cleaning system 100 comprises one or more of trachealventilation tube 160, ventilator 170, and/or suction source 601, in anycombination.

As used in the present application, including in the claims, a “trachealventilation tube” comprises an endotracheal tube (ETT) or a tracheostomytube. Suction source 601 provides a pressure less than one atm. As usedin the present application, including in the claims, a “fluid” comprisesliquid and/or gas, for example, a liquid-gas mixture that ispredominantly liquid, such as a liquid with gas bubbles. The liquid maycomprise water, such as saline solution or a disinfectant solution.

Cleaning system 100 comprises a distal ventilation tube-connectorassembly 158, a cleaning catheter 200, and an input module 156. Cleaningcatheter 200 comprises an elongate, flexible, tubular catheter main body210. As shown in FIG. 3, described hereinbelow, cleaning catheter 200includes a distal portion 212 located distal to ventilationtube-connector assembly 158, and a proximal portion 214 located proximalto ventilation tube-connector assembly 158. Distal portion 212 isconfigured to be inserted into ventilation tube 160. Proximal portion214 includes a proximal-most input portion 216 of catheter main body210, which is configured to be inserted into or is disposed within inputmodule 156. For some applications, proximal-most input portion 216 isaxially slidable with respect to input module 156, while for otherapplications, the proximal-most input portion is fixed with respect tothe input module. Respective lengths of distal and proximal portions 212and 214 may depend on an extent to which a distal end of catheter mainbody 210 is deployed within ventilation tube 160 and/or an extent towhich the distal end is longitudinally displaced from ventilationtube-connector assembly 158, for example, an extent to which cathetermain body 210 slides through ventilation tube-connector assembly 158 ina distal direction.

As used in the present application, including in the claims, “axial” and“axially” mean along an axis, and do not mean around or about an axis.For example: (a) “axial motion” means motion along an axis, and (b)“axially aligned” means aligned along an axis.

Ventilation tube-connector assembly 158 comprises: (a) a ventilator port664, configured to be coupled in fluid communication with ventilator 170via a ventilator connection tube 910, (b) a ventilation tube port,configured to be coupled in fluid communication with a proximal end ofventilation tube 160, and (c) a main body inlet, which is configured toallow passage therethrough of catheter main body 210.

In some applications of the present invention, cleaning system 100 isoperative to clean an interior of ventilation tube 160 when ventilationtube-connector assembly 158 is directly or indirectly connected to bothventilation tube 160 and ventilator 170 so as to mediate a substantiallyair-tight connection (e.g., via an interior chamber(s) and/or conduit(s)of ventilation tube-connector assembly 158) between the ventilator andan interior of the ventilation tube.

Cleaning catheter 200 further comprises an inflatable element 588, suchas a balloon, which is mounted to catheter main body 210 near a distalend of catheter main body 210. e.g., within 3 cm, such as within 1 cm,of the distal end, and/or in a distal half of distal portion 212 ofcleaning catheter 200, such as a distal third, a distal fifth, or adistal tenth of distal portion 212. Alternatively or additionally,inflatable element 588 is mounted to catheter main body 210 within 3 cm,e.g., within 1 cm, of at least one of the one or more distal suctionorifices 440, described hereinbelow. Inflatable element 588 isinflatable into contact with an inner surface of ventilation tube 160.For some applications, inflatable element 588 has a greatest outerdiameter of at least 6 mm, no more than 12 mm, and/or between 6 and 12mm when inflated at 1 bar above atmospheric pressure and unconstrained(i.e., not constrained by the ventilation tube or anything else), whichis typically slightly greater than an inner diameter of ventilation tube160, in order to provide sealing contact with the inner surface of theventilation tube. For some applications, inflatable element 588 has avolume of at least 0.5 cc, no more than 2 cc, and/or between 0.5 and 2cc when inflated at 1 bar above atmospheric pressure and unconstrained.For some applications, inflatable element 588 is elastic, while forother applications inflatable element 588 is not elastic. For someapplications, inflatable element 588 comprises a thin pliable material,such that the inflatable element crumples when deflated.

For some applications, catheter main body 210 has an outer diameter ofat least 6 mm, no more than 12 mm, and/or between 6 and 12 mm. For someapplications, the greatest outer diameter of inflatable element 588 whenfully inflated and unconstrained (i.e., not constrained by theventilation tube or anything else) equals at least 60%, no more than120%, and/or between 60% and 120% of the outer diameter of catheter mainbody 210.

Reference is now made to FIG. 3, which is a schematic illustration ofcatheter main body 210, in accordance with an application of the presentinvention. Catheter main body 210 includes at least the following lumensarranged along catheter main body 210. For some applications, one ormore of the lumens are arranged along catheter main body 210 at leastpartially within the main body, e.g., integrally formed in the cathetermain body 210, formed in the wall of catheter main body 210, or providedas a separate tube with catheter main body 210. Alternatively oradditionally, one or more of the lumens are arranged along catheter mainbody 210 at least partially outside the main body, e.g., provided as aseparate tube outside catheter main body 210. The lumens include:

-   -   at least one inflation lumen 520, which provides fluid        communication between at least one inflation inlet 521 and at        least one inflation port 585 which is in fluid communication        with an interior of inflatable element 588; typically, input        portion 216 is shaped so as to define inflation inlet 521, and        distal portion 212 is shaped so as to define inflation port 585;        and    -   one or more suction lumens 530, which provide fluid        communication between at least one proximal suction inlet 531        and the one or more distal suction orifices 440: typically,        input portion 216 of catheter main body 210 is shaped so as to        define proximal suction inlet 531, and distal portion 212 of        cleaning catheter 200 is shaped so as to define distal suction        orifices 440. The one or more suction lumens 530 are arranged in        intermittent fluid communication with suction source 601, as        described in detail hereinbelow; for applications in which the        one or more suction lumens 530 comprise a plurality of suction        lumens 530, the one or more suction lumens 530 typically are        arranged in fluid communication with one another (and are thus        typically brought into fluid communication with suction source        601 together rather than separately).

Inflation lumen 520 typically has a cross-sectional area smaller thanthat of suction lumen 530, e.g., less than 50%, less than 30%, or lessthan 20% of the cross-sectional area of suction lumen 530.

Reference is still made to FIG. 3, and is again made to FIGS. 1 and 2.When inflated, inflatable element 588 typically provides two types offunctionality: (i) flow obstruction functionality to significantlyhinder fluid flow between locations on opposite longitudinal sides ofthe inflatable element, and/or (ii) wiping functionality useful forcleaning the inner surface of ventilation tube 160. Typically, cleaningsystem 100 operates in a closed system environment.

During one state of operation, cleaning system 100 cleans the innersurface of ventilation tube 160 when ventilation tube-connector assembly158 mediates a substantially air-tight seal between (i) ventilator 170and/or an interior of ventilator port 664 and (ii) an interior ofventilation tube 160 and/or an interior of the ventilation tube port.

Concurrently with maintaining of this ventilation machine-ventilatortube seal, inflatable element 588 may be positioned within ventilationtube 160 (e.g., in a distal portion of ventilation tube 160), forexample by moving a distal end of catheter main body 210 in a distaldirection towards a distal end of ventilation tube 160. For example,inflatable element 588 may be distally advanced when inflatable element588 is in a non-contact state (i.e., not in contact with the innersurface of ventilation tube 160). After inflatable element 588 is thuspositioned, inflation of the inflatable element induces contact betweenan outer surface of inflatable element 588 and the inner surface ofventilation tube 160 and/or obstructs (i.e., significant hinders)longitudinal flow between proximal and distal portions of the interiorof ventilation tube 160.

Upon inflation of inflatable element 588 when the inflatable element ispositioned within ventilation tube 160, the inflated inflatable elementforms a sliding boundary which obstructs (i.e., significantly hinders)fluid flow to between: (a) a more proximal portion of an interstitialregion outside of catheter main body 210 and within ventilation tube 160and (b) locations within the ventilation tube 160 that are distal to theslidable boundary formed and delineated by inflatable element 588. Thisslidable boundary between the proximal and distal portions may be usefulfor facilitating the cleaning of the inner surface of ventilation tube160 (by wiping), for example for substantially confining locations ofnegative pressure and/or fluid (e.g., pressurized fluid) introduced intoan interstitial region outside of catheter main body 210 and withinventilation tube 160 so that the suction is introduced predominantly inthe proximal portion of ventilation tube 160.

Distal portion 212 of cleaning catheter 200 (labeled in FIG. 3) isshaped so as to define one or more distal suction orifices 440,typically through a lateral wall of distal portion 212. Typically, theone or more distal suction orifices 440 are located along distal portion212 at one or more respective locations proximal to inflatable element588. Typically, at least one of distal suction orifices 440 (such as allof the one or more distal suction orifices 440) is located within 1 cmof inflatable element 588, such as within 0.8 cm. e.g., within 0.5 cm ofthe inflatable element. For some applications, distal suction orifices440 have a total cross-sectional area in aggregate of at least 2 mm2, nomore than 25 mm2, and/or between 2 and 25 mm2, such as at least 4 mm2,no more than 16 mm2, and/or between 4 and 16 mm2.

Distal suction orifices 440 are supplied with negative pressure bysuction source 601 and facilitate cleaning of the inner surface ofventilation tube 160. For some applications, material within theinterior of ventilation tube 160 may be suctioned into distal suctionorifices 440 and proximally transported out of ventilation tube 160,e.g., to a location that is proximal to ventilation tube-connectorassembly 158. As described below in detail, fluid communication betweensuction source 601 and distal suction orifices 440 may be provided byone or more connecting lumens within or along catheter main body 210. Asused in the present application, including in the claims, “fluidcommunication” includes both positive and negative pressure fluidcommunication, and thus includes, for example, communication of apositive pressure or of a suction force.

For some applications, cleaning system 100 comprises a substantiallyimpermeable and/or pliable sleeve 610 for protecting an outer surface ofcatheter main body 210. In some embodiments, sleeve 610 envelops,surrounds, and/or protects at least some (e.g., at least a majority orat least a substantial majority, e.g., at least 75% or substantially allof (e.g., at least 90%)) of an outer surface of aventilation-tube-connector-assembly-proximal portion 214 of cathetermain body 210, typically in locations proximal to tube-connectorassembly 158 and distal to suction port 830 (described hereinbelow), andtypically to inhibit contamination. For some applications, sleeve 610provides this enveloping and/or protection functionality when a lengthof the ventilation-tube-connector-assembly-proximal portion 214 (labeledin FIG. 3) of catheter main body 210 is at least 5 cm, e.g., at least 10cm, at least 15 cm, or at least 20 cm.

For some applications, a length of proximal portion 214 may be modifiedby sliding, in a proximal or distal direction, catheter main body 210through ventilation tube-connector assembly 158.

For some applications, a distal end of sleeve 610 is (i) directly orindirectly attached to and/or (ii) has a location that is fixed and/orlongitudinally fixed relative to ventilation tube-connector assembly158. For some applications, a longitudinal position of a location of thedistal end of sleeve 610 corresponds to a location on ventilationtube-connector assembly 158 (e.g., at or near the main body inlet)and/or is longitudinally displaced from a proximal end (e.g.,corresponding to the main body inlet) of ventilation tube-connectorassembly 158 by at most 5 cm, e.g., at most 3 cm, at most 2 cm, or atmost 1 cm, and/or at most 50%, e.g., at most 30%, at most 20%, at most10% of a length of ventilation-tube-connector-assembly-proximal portion214 of catheter main body 210.

For some applications, a location of the distal end of sleeve 610 is notfixed relative to catheter main body 210. For example, catheter mainbody 210 may be longitudinally slidable within the sleeve 610 at or neara location of the distal end. Alternatively or additionally, for someapplications, a location of a proximal end of sleeve 610 is fixed and/orlongitudinally fixed relative to a proximal end of catheter main body210. For some applications, sleeve 610 forms a substantially air-tightseal between the external environment and an outer surface ofventilation-tube-connector-assembly-proximal portion 214 of cathetermain body 210 and/or between the external environment and region ofspace outside of an outer surface ofventilation-tube-connector-assembly-proximal portion 214 of cathetermain body 210 and within sleeve 610.

Reference is now made to FIG. 4, which is a schematic cross-sectionalillustration of a closed suction cleaning system 400 in a firstfluid-control state, in accordance with an application of the presentinvention. Reference is also made to FIGS. 5A-B, which are schematiccross-sectional illustrations of a portion of closed suction cleaningsystem 400 in the first fluid-control state and a second fluid-controlstate, respectively, in accordance with an application of the presentinvention. Closed suction cleaning system 400 is one implementation ofclosed suction cleaning system 100, described hereinabove with referenceto FIGS. 1-3. For illustrative purposes, inflatable element 588 is showninflated in FIG. 4, even though the inflatable element is in practicenot inflated in the first fluid-control state shown in FIG. 4, asdescribed hereinbelow.

As mentioned above, in some configurations input portion 216 of proximalportion of catheter main body 210 is configured to be inserted into oris disposed within, and axially slidable with respect to, input module156. Input module 156 has at least one port for connection with a fluidsource, including at least suction source 601. Input module 156 iscoupled to cleaning catheter 200, and comprises:

-   -   an inflation module 330, which comprises an inflation chamber        335 separate from suction source 601;    -   a flow regulator 700, which is (a) shaped so as to define        suction port 830, which is coupleable in fluid communication        with suction source 601 via a suction connection tube 920, and        coupled in fluid communication with suction source 601 during        use of cleaning system 100, and (b) configured to assume at        least first and second fluid-control states;    -   a mechanical user control element 320, which is configured (a)        to mechanically and non-electrically set the fluid-control        states of flow regulator 700, (b) to assume at least first and        second configurations, and (c) to mechanically and        non-electrically increase pressure in an interior of inflation        chamber 335 during at least a portion of a transition of        mechanical user control element 320 from the first configuration        to the second configuration; and    -   typically, a housing 310 encasing input portion 216 of catheter        main body 210.

For some applications, the first and second configurations of mechanicaluser control element 320 are first and second spatial positions,respectively. Mechanical user control element 320 is configured toassume at least the first and the second spatial positions.

For some applications, input module 156 comprises exactly one mechanicaluser control element 320 having the properties described herein, and/orsystem 100 comprises exactly one mechanical user control element 320having the properties described herein.

Input module 156 and/or system 100 may comprise further user controlelements that perform control functions in addition to those performedby mechanical user control element 320.

Input module 156 is arranged such that:

-   -   at least when mechanical user control element 320 is in the        first configuration (e.g., spatial position), as shown in FIGS.        2, 4, and 5A, flow regulator 70X) is in the first fluid-control        state, in which flow regulator 700 blocks fluid communication        between suction source 601 and distal suction orifices 440,    -   at least when mechanical user control element 320 is in the        second configuration (e.g., spatial position), as shown in FIG.        5B, flow regulator 700 is in the second fluid-control state, in        which flow regulator 70X) (A) connects suction source 601 and        distal suction orifices 440 in fluid communication, and (B)        connects the interior of inflation chamber 335 and an interior        of inflatable element 588 in fluid communication to inflate        inflatable element 588, and    -   flow regulator 700 is (a) not in the first fluid-control state        when mechanical user control element 320 is in the second        configuration, and (b) not in the second fluid-control state        when mechanical user control element 320 is in the first        configuration.

Typically, mechanical user control element 320 is able to assume aninfinite number of intermediate configurations (e.g., spatial positions)between the first configuration and the second configuration, asmechanical user control element 320 transitions between the firstconfiguration and the second configuration and vice versa. For someapplications, mechanical user control element 320 is arranged to movebetween first and second spatial end-points, and the first and thesecond spatial positions correspond with the first and the secondspatial end-points, respectively, as shown. Alternatively, the first andthe second spatial positions do not correspond with the first and thesecond spatial end-points, respectively (configuration not shown), butinstead the first spatial position and/or the second spatial positionare between the first and the second spatial end-points. For someapplications, the above-mentioned intermediate configurations includethe third intermediate configuration (e.g., spatial position) describedhereinbelow with reference to FIG. 5C.

Input module 156 is typically arranged such that flow regulator 700 isin the first fluid-control state not only when mechanical user controlelement 320 is in the first configuration (e.g., spatial position), asshown in FIGS. 2, 4, and 5A, but also during a portion of theintermediate configurations (e.g., spatial positions), which aretypically contiguous with the first configuration (e.g., spatialposition). Similarly, input module 156 is typically arranged such thatflow regulator 700 is in the second fluid-control state not only whenmechanical user control element 320 is in the second configuration(e.g., spatial position), as shown in FIG. 5B, but also during a portionof the intermediate configurations (e.g., spatial positions), which aretypically contiguous with the second configuration (e.g., spatialposition). For applications in which the intermediate configurationsinclude the third, intermediate configuration (e.g., spatial position)described hereinbelow with reference to FIG. 5C, input module 156 istypically arranged such that flow regulator 700 is in the thirdfluid-control state not only when mechanical user control element 320 isin the third configuration (e.g., spatial position), as shown in FIG.5C, but also during a portion of the intermediate configurations (e.g.,spatial positions), which are typically contiguous with the thirdconfiguration (e.g., spatial position).

As mentioned above, mechanical user control element 320 is configured tomechanically and non-electrically increase pressure in an interior ofinflation chamber 335 during at least a portion of the transition ofmechanical user control element 320 from the first configuration to thesecond configuration. For some applications, mechanical user controlelement 320 is configured to mechanically and non-electrically increasethe pressure in the interior of inflation chamber 335 during an entiretyof the transition of mechanical user control element 320 from the firstconfiguration to the second configuration.

For some applications, input module 156 is configured such that duringthe at least a portion of the transition of mechanical user controlelement 320 from the first configuration to the second configuration,before flow regulator 700 assumes the second fluid-control state, avolume of the interior of inflation chamber 335 decreases by at least10%, such as at least 20%, 30%, 40%, or 50%, and/or no more than 90%,such as no more than 80% or 70%, e.g., by between 10% and 90%. In otherwords, the pressure in inflation chamber 335 increases substantiallybefore fluid communication is established between the interior ofinflation chamber 335 and the interior of inflatable element 588.

For some applications, the mechanical user control element 320 isconfigured to mechanically and non-electrically increase the pressure inthe interior of inflation chamber 335 during motion of mechanical usercontrol element 320 while flow regulator 700 is in the secondfluid-control state. For example, the pressure may (a) continue toincrease while flow regulator 700 is in the second fluid-control state,(b) increase only while flow regulator 700 is in the secondfluid-control state, or (c) increase only while flow regulator 700 is inthe second and the third fluid-control states.

As mentioned above, mechanical user control element 320 is configured tomechanically and non-electrically increase pressure in the interior ofinflation chamber 335 during at least a portion of the transition ofmechanical user control element 320 from the first configuration to thesecond configuration. For some applications, as labeled in FIG. 5B, ahealthcare worker applies a first force F1 to mechanical user controlelement 320 (such as to a user control handle 718 thereof), and a secondforce F2, directed toward the first force F1, to the opposite side ofinput module 156 from mechanical user control element 320. Typically,mechanical user control element 320 is transitioned between the firstand the second configurations when the distal end of catheter main body210 is axially disposed in ventilation tube 160 at a location moredistal than an axial mid-point of ventilation tube 160, typically nearthe distal end of ventilation tube 160 (typically within 2 cm of thedistal end).

Typically, flow regulator 700:

-   -   when in the first fluid-control state, connects suction source        601 and the interior of inflatable element 588 in fluid        communication via an outlet 337 of inflation chamber 335 and        inflation lumen 520, and    -   when in the second fluid-control state, connects in fluid        communication (a) suction source 601 and distal suction orifices        440 via the one or more suction lumens 530, and (b) the interior        of inflation chamber 335 and the interior of inflatable element        588 via inflation lumen 520.

Optionally, seals 342 and 343 are provided to seal around outlet 337.

For some applications, such as shown in FIGS. 2, 3, 4, and 5A-B, inputmodule 156 is arranged such that:

-   -   when mechanical user control element 320 is in the first        configuration (e.g., spatial position) and flow regulator 700 is        in the first fluid-control state, as shown in FIGS. 2, 4 and 5A,        flow regulator 700 connects suction source 601 and the interior        of inflatable element 588 in fluid communication to deflate        inflatable element 588, and    -   when mechanical user control element 320 is in the second        configuration (e.g., spatial position) and flow regulator 700 is        in the second fluid-control state, as shown in FIG. 5B, flow        regulator 700 does not connect suction source 601 and the        interior of inflatable element 588 in fluid communication.

In these applications, typically flow regulator 700, when in the secondfluid-control state, connects in fluid communication suction source 601and distal suction orifices 440 via the one or more suction lumens 530.

Typically, each of the first and the second configurations of mechanicaluser control element 320 includes a range of spatial positions, suchthat each of the first and the second fluid-control states of flowregulator 700 is stably activated over the respective range of spatialpositions, rather than only at single respective spatial positions ofmechanical user control element 320. Providing these ranges of spatialpositions obviates the need for the user to precisely positionmechanical user control element 320 in order to achieve the differentfluid-control states.

For some of these applications, inflation module 330 comprises a one-wayair inlet valve 331, which is arranged to allow air to flow intoinflation chamber 335 during at least a portion of a transition ofmechanical user control element 320 from the second configuration to thefirst configuration. One-way air inlet valve 331 allows ambient air 199to enter (be sucked into) inflation chamber 335 as inflation chamber 335expands during at least a portion of a transition between the secondfluid-control state to the first fluid-control state. For someapplications, one-way air inlet valve 331 is configured to generate asound signal during at least a portion of a period of fluid flow intoinflation chamber 335 and/or during deflation of inflatable element 588;for example, one-way air inlet valve 331 may be shaped so as to define awhistle.

In the configuration illustrated in FIGS. 1-2, 4, 5A-C, 8-9, 10, and11A-C the two fluid-control states are actuated by axial motion ofproximal portion 214 of catheter main body 210 relative to input modulehousing 310. For some applications, transitions between the two statesare caused by shifts in alignment of the lumen inlets with respect tovarious chambers of input module 156, which chambers are or are not influid communication with respective ports. The shifts in alignment aretypically caused via axial motion of input portion 216 of catheter mainbody 210 within input module housing 310, along the longitudinal axes ofinput portion 216 and input module 156. For some applications, inputmodule 156 is arranged such that changes in configuration of mechanicaluser control element 320 cause corresponding changes in axial positionof input portion 216 with respect to input module 156. Typically, forthese applications, input module 156 is arranged such that input portion216 assumes first and second axial positions with respect to inputmodule 156, corresponding to the first and the second configurations ofmechanical user control element 320.

Typically, suction port 830 is shaped as a conventional suction port inaccordance with hospital standards for coupling to standard hospitalsuctions sources. For example, suction port 830 may have a male conicalinterface, such as shown in FIGS. 2, 4, 5A-C, 8-9, 10, and 11A-C.Typically, suction port 830 has a lumen size that corresponds with thelumen size of conventional tracheal suction lumens, which generallyhaving a gauge of between 5 Fr to 18 Fr.

Reference is now made to FIG. 5C, which is a schematic cross-sectionalillustration of a portion of closed suction cleaning system 400 in athird fluid-control state, in accordance with an application of thepresent invention. For some applications, cleaning system 400 may alsobe used for suctioning the trachea outside of and distal to ventilationtube 160, typically when flow regulator 700 is in one of the followingstates:

-   -   as shown in FIG. 5B, the second fluid-control state, in which        suction source 601 and distal suction orifices 440 are in fluid        communication (and inflatable element 588 is inflated), or    -   as shown in FIG. 5C, a third, intermediate fluid-control state,        between the first and the second fluid-control states, in        which (a) suction source 601 and distal suction orifices 440 are        in fluid communication with one another, and (b) the interior of        inflation chamber 335 and the interior of inflatable element 588        are not in fluid communication with one another, and inflatable        element 588 is thus not inflated.

For some applications, flow regulator 700 is configured to assume thethird, intermediate fluid-control state when mechanical user controlelement 320 is in a third, intermediate configuration (e.g., spatialposition), as shown in FIG. 5C, between the first configuration (e.g.,spatial position), as shown in FIG. 5A, and the second configuration(e.g., spatial configuration), as shown in FIG. 5B.

For some applications, when mechanical user control element 320 is inthe third, intermediate configuration and flow regulator 700 is in thethird, intermediate fluid-control state:

-   -   inflation inlet 521 is not in fluid communication with outlet        337 of inflation chamber 335; typically, inflation inlet 521 is        in fluid communication with suction port 830, such as via at        least one suction channel 831, to maintain inflatable element        588 deflated, as shown in FIG. 5C (alternatively, inflation        inlet 521 is axially aligned with a wall of input module housing        310, e.g., slightly proximal to (i.e., to the right of, in FIG.        5B) the position of inflation inlet 521 shown in FIG. 5B (and        thus slightly proximal to outlet 337), because catheter main        body 210 is positioned slightly proximal to (i.e., to the right        of, in FIG. 5B) the position shown in FIG. 5B), and    -   as shown in FIG. 5C, proximal suction inlet 531 is in fluid        communication with suction port 830, such as via at least one        suction channel 831, e.g., with proximal suction inlet 531        disposed slightly proximal to (i.e., to the right of, in FIG.        5B) the position of proximal suction inlet 531 shown in FIG. 5B,        but not so proximal (e.g., far to the right in FIG. 5B) as to        form a seal with suction sealer 375.

Typically, as described above regarding the first and the secondconfigurations of mechanical user control element 320, the thirdconfiguration of mechanical user control element 320 includes a range ofspatial positions, such that the third fluid-control state of flowregulator 700 is stably activated over the range of spatial positions,rather than only at a single spatial position of mechanical user controlelement 320. Providing this range of spatial positions obviates the needfor the user to precisely position mechanical user control element 320in order to achieve the third fluid-control states.

As mentioned above, for some of these applications, when mechanical usercontrol element 320 is in the third, intermediate configuration and flowregulator 700 is in the third, intermediate fluid-control state,inflation inlet 521 is in fluid communication with suction port 830, asshown in FIG. 5C. For others of these applications, when mechanical usercontrol element 320 is in the third, intermediate configuration and flowregulator 700 is in the third, intermediate fluid-control state,inflation inlet 521 is not in fluid communication with suction port 830(configuration not shown).

For some applications, during a transition of mechanical user controlelement 320 between the first configuration and the secondconfiguration, mechanical user control element 320 assumes a transientposition in which inflation inlet 521 is neither in fluid communicationwith suction port 830 nor in fluid communication with outlet 337 ofinflation chamber 335. Typically, the transient position has a shorterrange of spatial positions than do the first, the second, and the thirdconfigurations of mechanical user control element 320, as describedabove.

For some applications, the distal end of catheter main body 210 isclosed (such as shown). In these applications, tracheal suction istypically performed by advancing catheter main body 210 far enoughbeyond the distal end of ventilation tube 160 such that at least one ofthe one or more distal suction orifices 440 is in fluid communicationwith the interior of the trachea distally beyond the end of ventilationtube 160. For other applications, catheter main body 210 is shaped so asto define, in addition to the one or more distal suction orifices 440, adistal-most suction orifice at a distal end of distal portion 212 ofcleaning catheter 200, distal to inflatable element 588, for examplesuch as described in above-mentioned U.S. Pat. No. 8,999,074, withreference to FIGS. 21A-B and 22A-C thereof.

For some applications, input module 156 is configured such that changesin configuration (e.g., spatial position) of mechanical user controlelement 320 cause corresponding changes in axial position of inputportion 216 of catheter main body 210 with respect to input module 156.Typically, input module 156 is configured such that input portion 216assumes first and second axial positions with respect to input module156 (e.g., with respect to suction port 830), corresponding to the firstand the second configurations (e.g., spatial positions) of mechanicaluser control element 320. The first and the second axial positions ofinput portion 216 are typically along a single axis.

For some applications, such as shown in FIGS. 2, 4, 5A-C, 6A-C, and 7,mechanical user control element 320 is configured to increase thepressure in the interior of inflation chamber 335 by mechanically andnon-electrically compressing inflation chamber 335 during the at least aportion of the transition of mechanical user control element 320 fromthe first configuration to the second configuration. In theseapplications, inflation chamber 335 functions as a compression pump. Forsome applications, mechanical user control element 320 is directly orindirectly coupled to one or more external surfaces of inflation chamber335. Alternatively, as shown in FIGS. 1-2, 4, 5A-C, and 8-9, mechanicaluser control element 320 and inflation chamber 335 are not directlycoupled together, but are arranged such that activation (e.g., movement)of mechanical user control element 320 applies a force to inflationchamber 335. For example, mechanical user control element 320 andinflation module 330 (and inflation chamber 335) may be arranged suchthat user control handle 718 or a button of mechanical user controlelement 320 applies a force to a top surface of inflation module 330(e.g., inflation chamber 335) when the handle or button is pressedtoward an axis of input module 156. Alternatively, for example,inflation chamber 30 may be disposed at least partially withinmechanical user control element 320 (such as described hereinbelow withreference to FIGS. 6A-C and 7). Other configurations will be readilyapparent to one of ordinary skill in the art who has read the presentapplication, and are within the scope of the present application.

For some applications, as shown in FIGS. 1-2, 4, 5A-C, 6A-C, 7, and 8-9,inflation chamber 335 transitions from a lower level of compression to ahigher level of compression during the at least a portion of thetransition of mechanical user control element 320 from the firstconfiguration to the second configuration. For some of theseapplications, input module 156 is configured to elastically biasinflation chamber 335 toward the lower level of compression. For someapplications, inflation chamber 335 (e.g., at least one wall 332 ofinflation chamber 335) is elastically biased toward the lower level ofcompression. For example, the at least one wall of inflation chamber 335may be accordion-shaped and/or the chamber walls comprise an elasticmaterial, such as silicon, rubber, or polyurethane. In some embodiments,substantially no friction needs to be overcome during expansion ofinflation chamber 335. Alternatively or additionally, inflation module330 (such as inflation chamber 335) comprises a distinct elastic element333 (e.g., a spring) that is arranged to bias inflation chamber 335toward the lower level of compression. Alternatively or additionally,mechanical user control element 320 is elastically biased toward thelower level of compression (and to the first configuration), for exampleby a spring 349. In any event, typically, when user control element 320is released, inflation chamber 335 expands. In other words, input module156 is biased to assume the first configuration and first fluid-controlstate when in a resting state, such that inflation chamber 335 is in anexpanded state when input module 156 is in the resting state.

For some applications, input module 156 further comprises a user signalgenerator 350, which is configured to generate a user signal (e.g., asound) during at least a portion of a period of fluid flow intoinflation chamber 335 and/or during or upon deflation of inflatableelement 588. The user signal generator may be electrical and/ormechanical.

For some applications, inflation chamber 335 has a volume of at least 1cc, no more than 10 cc, and/or between 1 and 10 cc (e.g., at least 1.5cc, no more than 3 cc, and/or between 1.5 and 3 cc), when mechanicaluser control element 320 is in the first configuration (i.e., notcompressed). The volume typically equals more than 1 times and less than3 times the volume of inflatable element 588. Typically, when mechanicaluser control element 320 is in the second configuration (i.e.,compressed), inflation chamber 335 has a volume of at least 1 cc lessthan when mechanical user control element 320 is in the firstconfiguration (i.e., not compressed).

Reference is made to FIGS. 4 and 5A-C. For some applications, as shownin these figures, catheter main body 210 is shaped so as to defineproximal suction inlet 531 at a proximal end of the main body. For someof these applications, proximal suction inlet 531 is configured tosealingly engage a suction sealer 375 that is fixed with respect tohousing 310. When flow regulator 700 is in the first fluid-controlstate, proximal suction inlet 531 is sealingly engaged with suctionsealer 375 (as shown in FIGS. 4 and 5A), thereby blocking (a) fluidcommunication between proximal suction inlet 531 and suction port 830,and (b) fluid communication between suction source 601 and lumen 530.When flow regulator 700 is in the second fluid-control state, proximalsuction inlet 531 is disengaged from suction sealer 375 (as shown inFIG. 5B), thereby enabling fluid communication between proximal suctioninlet 531 and suction port 830. This engaging/disengaging is typicallyactuated by axial motion of catheter main body 210 with respect tosuction sealer 375.

Typically, as shown in FIG. 5B, at least one suction channel 831facilitates fluid communication to suction port 830 around the suctionsealer 375. Therefore, when inflation inlet 521 is in fluidcommunication with suction channel 831, suction is communicated toinflation lumen 520, while suction remains blocked by suction sealer 375from communication to one or more suction lumens 530. As a result,suction deflation of inflatable element 588 is caused while no suctionis communicated to distal suction orifices 440 of the catheter mainbody.

For some applications, as shown in FIGS. 1-2, 4, 5A-C, and 8-9,mechanical user control element 320 comprises user control handle 718,the movement of which includes a component perpendicular to theassociated axial motion of catheter main body 210.

Mechanical user control element 320 translates the movement of usercontrol handle 718 into axial motion of catheter main body 210. Forexample, mechanical user control element 320 may comprise a sideprojection element 730 attached to catheter main body 210, and anengaging element 711 that has a diagonal face which engages sideprojection element 730, such that when engaging element 711 moves down,it pushes side projection element 730 sideways and thus imparts axialmotion to catheter main body 210.

Reference is now made to FIGS. 6A-C, which are schematic cross-sectionalillustrations of a closed suction cleaning system 500 in a firstfluid-control state, a third intermediate fluid-control state, and asecond fluid-control state, respectively, in accordance with anapplication of the present invention. Reference is also made to FIG. 7,which is another schematic cross-sectional illustration of closedsuction cleaning system 500 in the first fluid-control state, inaccordance with an application of the present invention. Closed suctioncleaning system 500 is one implementation of closed suction cleaningsystem 100, described hereinabove with reference to FIGS. 1-3, and,except as described hereinbelow, may implement any of the featuresdescribed hereinabove with reference to FIG. 1-3.

Unlike in the other configurations described herein, in closed suctioncleaning system 500, the fluid-control states are not actuated by axialmotion of proximal portion 214 of catheter main body 210 relative toinput module housing 310, and mechanical user control element 320 doesnot translate the movement of user control handle 718 into axial motionof catheter main body 210. Instead, in closed suction cleaning system500, proximal-most input portion 216 of catheter main body 210 is fixedwith respect to input module 156. The movement of user control handle718 actuates the fluid-control states without translating the movementinto axial motion of proximal portion 214 of catheter main body 210.Input module 156 is arranged such that user control handle 718 ismoveable with respect to catheter main body 210 in two oppositedirections along a movement axis 618 that forms a fixed angle 3 (beta)of between 45 and 135 degrees with a central longitudinal axis 620 ofproximal-most input portion 216 of catheter main body 210, typically 90degrees (as shown). Input module 156 is arranged such that movement ofuser control handle 718 along movement axis 618 mechanically causescorresponding movement of a distal opening 832 of suction port 830 alongor alongside movement axis 618. This corresponding movement selectivelybrings distal opening 832 of suction port 830 into and out of fluidcommunication with (a) the interior of inflatable element 588 (viainflation lumen 520 of catheter main body 210), and (b) distal suctionorifices 440 (via suction lumen 530 of catheter main body 210), asdescribed hereinbelow in detail. (Typically, input module 156 isarranged such that user control handle 718 is constrained to movementwith respect to catheter main body 210 only along movement axis 618, andnot in other directions.)

For some applications, module 156 is arranged such that movement of usercontrol handle 718 along movement axis 618 mechanically causescorresponding movement of suction port 830 along or alongside movementaxis 618, in addition to causing corresponding movement of distalopening 832 of suction port 830. For some of these applications, alongitudinal axis of suction port 830 is perpendicular to movement axis618, and thus the longitudinal axis of suction port 830 moves along oralongside movement axis 618.

For some applications, mechanical user control element 320 is shaped soas to define first and second fluid-connection chambers 631 and 632,which are arranged at respective different locations along or alongsidemovement axis 618, with first fluid-connection chamber 631 farther fromcatheter main body 210 than second fluid-connection chamber 632 is fromcatheter main body 210. For some applications, first and secondfluid-connection chambers 631 and 632 are annular (as shown). Forexample, in order to define the chambers, mechanical user controlelement 320 may be shaped so as to define, or comprise, first, second,and third sealing rings 641, 642, and 643 (e.g., 0-rings), arranged suchthat first and second sealing rings 641 and 642 define firstfluid-connection chamber 631, and second and third sealing rings 642 and643 define second fluid-connection chamber 632.

For some applications, mechanical user control element 320 is shaped soas to define:

-   -   an inflation lumen 637, which connects, in fluid communication,        inflation inlet 521 of catheter main body 210 and first        fluid-connection chamber 631, via an inflation lumen port 650        defined by inflation lumen 637, and    -   a suction lumen 638, which connects, in fluid communication,        proximal suction inlet 531 of catheter main body 210 and second        fluid-connection chamber 632, via a suction lumen port 652        defined by suction lumen 638.

Inflation lumen port 650 may be disposed at or near an end of inflationlumen 637 opposite the end connected to inflation inlet 521 of cathetermain body 210, as shown. Suction lumen port 652 may be disposed at ornear an end of suction lumen 638 opposite the end connected to proximalsuction inlet 531 of catheter main body 210, as shown.

Input module 156 is arranged such that when mechanical user controlelement 320 (e.g., user control handle 718 thereof) is in a firstconfiguration (e.g., spatial position) along movement axis 618, as shownin FIGS. 6A and 7, flow regulator 700 is in the first fluid-controlstate, in which flow regulator 700:

-   -   connects suction source 601 and the interior of inflatable        element 588 in fluid communication via inflation lumen 520 to        deflate inflatable element 588; for example, distal opening 832        of suction port 830 may be in fluid communication with first        fluid-connection chamber 631, which in turn is in fluid        communication with inflation inlet 521 via inflation lumen 637        and, and    -   blocks fluid communication between suction source 601 and distal        suction orifices 440 via suction lumen 530; for example, distal        opening 832 of suction port 830 may not be in fluid        communication with second fluid-connection chamber 632.

Input module 156 is arranged such that when mechanical user controlelement 320 is in the second configuration (e.g., spatial position)along movement axis 618, as shown in FIG. 6C, flow regulator 700 is inthe second fluid-control state, in which flow regulator 700:

-   -   connects suction source 601 and distal suction orifices 440 in        fluid communication via suction lumen 530; for example, distal        opening 832 of suction port 830 may be in fluid communication        with second fluid-connection chamber 632, which in turn is in        fluid communication with proximal suction inlet 531 via suction        lumen 638, and    -   connects the interior of inflation chamber 335 and the interior        of inflatable element 588 in fluid communication to inflate        inflatable element 588; for example, outlet 337 of inflation        chamber 335 may be in fluid communication with first        fluid-connection chamber 631, which in turn is in fluid        communication with inflation inlet 521 via inflation lumen 637.

For some applications, input module 156 is arranged such that movementof user control handle 718 of mechanical user control element 320 alongmovement axis 618 mechanically causes corresponding movement along oralongside movement axis 618 of both:

-   -   distal opening 832 of suction port 830, which selectively brings        distal opening 832 of suction port 830 into and out of fluid        communication with (a) the interior of inflatable element 588        (via inflation lumen 520 of catheter main body 210), and (b)        distal suction orifices 440 (via suction lumen 530 of catheter        main body 210), and    -   outlet 337 of inflation chamber 335, which selectively brings        the interior of inflation chamber 335 into and out of fluid        communication with the interior of inflatable element 588 (via        inflation lumen 520 of catheter main body 210).

For some applications, during movement of user control handle 718 ofmechanical user control element 320 along movement axis 618, first andsecond fluid-connection chambers 631 and 632 remain stationary withrespect to catheter main body 210 (as shown), while for otherapplications, first and second fluid-connection chambers 631 and 632move with respect to catheter main body 210 (configuration not shown).

Reference is still made to FIGS. 6A-C and 7. For some applications, suchas described hereinabove with reference to FIGS. 5A-C, cleaning system100 may also be used for suctioning the trachea outside of and distal toventilation tube 160, typically when flow regulator 700 is in one of thefollowing states:

-   -   the second fluid-control state, in which suction source 601 and        distal suction orifices 440 are in fluid communication (and        inflatable element 588 is inflated), or    -   the third, intermediate fluid-control state, between the first        and the second fluid-control states, such as shown in FIG. 6B,        in which (a) suction source 601 and distal suction orifices 440        are in fluid communication with one another, and (b) the        interior of inflation chamber 335 and the interior of inflatable        element 588 are not in fluid communication with one another, and        inflatable element 588 is thus not inflated.

For some applications, flow regulator 700 is configured to assume thethird, intermediate fluid-control state when mechanical user controlelement 320 is in a third, intermediate configuration (e.g., spatialposition) along movement axis 618 between the first configuration (e.g.,spatial position) and the second configuration (e.g., spatialconfiguration), such as shown in FIG. 6B.

For some applications, such as shown in FIG. 6B, when mechanical usercontrol element 320 is in the third, intermediate configuration and flowregulator 700 is in the third, intermediate fluid-control state:

-   -   inflation inlet 521 is not in fluid communication with outlet        337 of inflation chamber 335 (because outlet 337 is not in fluid        communication with first fluid-connection chamber 631),    -   proximal suction inlet 531 is in fluid communication with        suction port 830, via suction lumen 638, second fluid-connection        chamber 632, and distal opening 832 of suction port 830, and    -   inflation inlet 521 is in fluid communication with suction port        830, via inflation lumen 637, first fluid-connection chamber        631, and distal opening 832 of suction port 830.

When flow regulator 700 is in the third, intermediate fluid-controlstate (shown in FIG. 6B), air pressure within inflation chamber 335 isgreater than when flow regulator 700 is in the first fluid-control state(shown in FIG. 6A), because inflation chamber 335 has been compressedbut the interior of the inflation chamber is not yet in fluidcommunication with any lumens, as the inflation chamber subsequently isin the second fluid-control state (shown in FIG. 6C).

When flow regulator 700 is in the third, intermediate fluid-controlstate, distal opening 832 of suction port 830 spans both first andsecond fluid-connection chambers 631 and 632 along or alongside movementaxis 618 (because distal opening 832 of suction port 830 is wider thansealing ring 642, measured along or alongside movement axis 618). As aresult, distal opening 832 of suction port 830 is simultaneously influid communication with both first and second fluid-connection chambers631 and 632.

For some applications, as shown in FIGS. 6A-C and 7, inflation chamber335 is disposed within mechanical user control element 320; for example,inflation chamber 335 may be defined by one or more interior surfaces ofuser control handle 718.

For some applications, inflation module 330 comprises a one-way airinlet valve 331, such as described hereinabove with reference to FIGS. 4and 5A-C.

Reference is now made to FIGS. 8-9, which are schematic cross-sectionalillustrations of a closed suction cleaning system 800 in first andsecond fluid-control states, respectively, in accordance with anapplication of the present invention. Closed suction cleaning system 800is one implementation of closed suction cleaning system 100, describedhereinabove with reference to FIGS. 1-3, and, except as describedhereinbelow, may implement any of the features described hereinabovewith reference to FIG. 1-3. Although closed suction cleaning system 800is shown in FIGS. 8-9 as implementing features of closed suctioncleaning system 400, described hereinabove with reference to FIGS. 4 and5A-C, closed suction cleaning system 800 may alternatively implementfeatures of closed suction cleaning system 500, described hereinabovewith reference to FIGS. 6A-C and 7, mutatis mutandis.

In closed suction cleaning system 800, inflation module 330 (includinginflation chamber 335) is arranged on the opposite side of input module156 from mechanical user control element 320. Outlet 337 of inflationmodule 330 may be connected to chamber 335 by a tube 802. Input module156 is arranged such that flow regulator 700 assumes the firstfluid-control state when in a resting state; to this end, mechanicaluser control element 320 is elastically biased toward the firstconfiguration, for example by spring 349, and inflation chamber 335 iselastically biased toward the lower level of compression, for example asdescribed hereinabove with reference to FIGS. 2, 4, 5A-C, 6A-C, and 7.

Simultaneous application of respective forces (labeled as first force F1and second force F2), directed toward each other, to mechanical usercontrol element 320 and inflation module 330 (and inflation chamber335), simultaneously:

-   -   transitions mechanical user control element 320 from the first        configuration to the second configuration, thereby transitioning        flow regulator 700 from the first fluid-control state to the        second fluid-control state, and    -   mechanically and non-electrically increases pressure in the        interior of inflation chamber 335, by compression of inflation        chamber 335.

The respective forces are typically applied by a healthcare workersqueezing mechanical user control element 320 and inflation module 330(and inflation chamber 335) toward each other, such as using the thumband fingers, respectively.

Reference is now made to FIG. 10, which is a schematic cross-sectionalillustration of a closed suction cleaning system 900 in a firstfluid-control state, in accordance with an application of the presentinvention. Reference is also made to FIGS. 11A-B, which are schematiccross-sectional illustrations of a portion of closed suction cleaningsystem 900 in the first fluid-control state and a second fluid-controlstate, respectively, in accordance with an application of the presentinvention. Closed suction cleaning system 900 is one implementation ofclosed suction cleaning system 100, described hereinabove with referenceto FIGS. 1-3, and, except as described hereinbelow, may implement any ofthe features of closed suction cleaning system 400 described hereinabovewith reference to FIGS. 4 and 5A-C. For illustrative purposes,inflatable element 588 is shown inflated in FIG. 10, even though theinflatable element is in practice not inflated in the firstfluid-control state shown in FIG. 10, as described herein.

In this configuration, input module 156 comprises a first mechanicaluser control element 320A, which is configured to mechanically andnon-electrically set the fluid-control states of flow regulator 700.First mechanical user control element 320A is configured to assume atleast first and second configurations, such as first and second spatialpositions, respectively. For some applications, as shown, firstmechanical user control element 320A comprises a first user controlbutton 930A.

In this configuration, input module 156 further comprises a secondmechanical user control element 320B, which is configured (a) to assumeat least first and second configurations, such as first and secondspatial positions, and (b) to mechanically and non-electrically increasepressure in the interior of inflation chamber 335 during a transition ofsecond mechanical user control element 320B from its first configurationto its second configuration. In these applications, inflation chamber335 functions as a compression pump. For some applications, as shown,second mechanical user control element 320B comprises a second usercontrol button 930B.

For some applications, input module 156 is arranged such that:

-   -   when first mechanical user control element 320A is in its first        configuration (e.g., spatial position), as shown in FIGS. 10 and        11A, flow regulator 700 is in the first fluid-control state, in        which flow regulator 700 blocks fluid communication between        suction source 601 and distal suction orifices 440, and    -   when first mechanical user control element 320A is in its second        configuration (e.g., spatial position), as shown in FIG. 11B,        flow regulator 700 is in the second fluid-control state, in        which flow regulator 700 (a) connects suction source 601 and        distal suction orifices 440 in fluid communication, and (b)        connects the interior of inflation chamber 335 and an interior        of inflatable element 588 in fluid communication to inflate        inflatable element 588.

For some applications, as labeled in FIG. 11B, a healthcare workerapplies:

-   -   a first force F1 to first mechanical user control element 320A        (such as to first user control button 930A thereof),    -   a third force F3 to second mechanical user control element 320B        (such as to second user control button 930B thereof), and    -   a second force F2, directed toward the first and the third        forces F1 and F3, to the opposite side of input module 156 from        first and second user control elements 320A and 320B.

For some applications, first and second mechanical user control elements320A and 320B (e.g., first and second user control buttons 930A and930B) are arranged side-by-side. For some applications, first and secondmechanical user control elements 320A and 320B (e.g., first and seconduser control buttons 930A and 930B) are arranged such that a portion ofone of the mechanical user control elements (e.g., control buttons) atleast partially (i.e., partially or entirely) surrounds the other usercontrol element (e.g., control button). For example, second mechanicaluser control element 320B (e.g., second user control button 930B) may atleast partially surround at least two sides of first mechanical usercontrol element 320A (e.g., first user control button 930A), such as atleast three sides (e.g., three entire sides) of first mechanical usercontrol element 320A (e.g., first user control button 930A), as shown inFIG. 10. Alternatively, for example, first mechanical user controlelement 320A (e.g., first user control button 930A) may at leastpartially surround at least two sides of second mechanical user controlelement 320B (e.g., second user control button 930B), such as at leastthree sides (e.g., three entire sides) of second mechanical user controlelement 320B (e.g., second user control button 930B) (configurations notshown). In these side-by-side arrangements, a closest distance betweenfirst and second mechanical user control elements 320A and 320B (e.g.,first and second user control buttons 930A and 930B) is typically atleast 0.1 mm, no more than 2 mm (e.g., no more than 1 mm), and/orbetween 0.1 mm and 2 mm (e.g., 1 mm).

Providing the control elements side-by-side may enable both (a)ergonomically-convenient simultaneous pressing of both control elements,such as to transition flow regulator 700 from the first fluid-controlstate to the second fluid-control state, and (b) pressing of only firstmechanical user control element 320A (e.g., first user control button930A) to transition flow regulator 700 from the first fluid-controlstate to a third fluid-control state, such as described hereinbelow.

Reference is now made to FIG. 11C, which is a schematic cross-sectionalillustration of a portion of closed suction cleaning system 900 in athird fluid-control state, in accordance with an application of thepresent invention. For some applications, cleaning system 900 may alsobe used for suctioning the trachea outside of and distal to ventilationtube 160, typically when flow regulator 700 is in one of the followingstates:

-   -   as shown in FIG. 11B, the second fluid-control state, in which        suction source 601 and distal suction orifices 440 are in fluid        communication (and inflatable element 588 is inflated), or    -   as shown in FIG. 11C, the third, intermediate fluid-control        state, between the first and the second fluid-control states, in        which (a) suction source 601 and distal suction orifices 440 are        in fluid communication with one another, and (b) the interior of        inflation chamber 335 and the interior of inflatable element 588        are not in fluid communication with one another, and inflatable        element 588 is thus not inflated.

For some applications, flow regulator 700 is configured to assume thethird, intermediate fluid-control state when:

-   -   first mechanical user control element 320A (e.g., first user        control button 930A) is in a third, intermediate configuration        (e.g., spatial position), as shown in FIG. 11C, between its        first configuration (e.g., spatial position), as shown in FIG.        11A, and its second configuration (e.g., spatial configuration),        as shown in FIG. 11B, and    -   second mechanical user control element 320B (e.g., second user        control button 930B) is in its first configuration (e.g.,        spatial position), as shown in FIG. 11C.

For some applications, when first mechanical user control element 320A(e.g., first user control button 930A) is in the third, intermediateconfiguration and flow regulator 700 is in the third, intermediatefluid-control state:

-   -   inflation inlet 521 is not in fluid communication with outlet        337 of inflation chamber 335; typically, inflation inlet 521 is        in fluid communication with suction port 830, such as via at        least one suction channel 831, to maintain inflatable element        588 deflated, as shown in FIG. 11C (alternatively, inflation        inlet 521 is axially aligned with a wall of input module housing        310, e.g., slightly proximal to (i.e., to the right of, in FIG.        11B) the position of inflation inlet 521 shown in FIG. 11B (and        thus slightly proximal to outlet 337), because catheter main        body 210 is positioned slightly proximal to (i.e., to the right        of, in FIG. 11B) the position shown in FIG. 11B), and    -   as shown in FIG. 11C, proximal suction inlet 531 is in fluid        communication with suction port 830, such as via at least one        suction channel 831, e.g., with proximal suction inlet 531        disposed slightly proximal to (i.e., to the right of, in FIG.        11B) the position of proximal suction inlet 531 shown in FIG.        11B, but not so proximal (e.g., far to the right in FIG. 11B) as        to form a seal with suction sealer 375.

Flow regulator 700 may have any of the features thereof describedhereinabove with reference to FIG. 5C, mutatis mutandis.

For other applications (configuration not shown), flow regulator 700 isconfigured to assume the third, intermediate fluid-control state when:

-   -   first mechanical user control element 320A (e.g., first user        control button 930A) is in the third, intermediate configuration        (e.g., spatial position), as shown in FIG. 11C, and    -   second mechanical user control element 320B (e.g., second user        control button 930B) is in a third, intermediate configuration        (e.g., spatial position), between its first configuration (e.g.,        spatial position), as shown in FIG. 11A, and its second        configuration (e.g., spatial configuration), as shown in FIG.        11B (configuration not shown).

For still other applications (configuration not shown), flow regulator700 is configured to assume the third, intermediate fluid-control statewhen:

-   -   first mechanical user control element 320A (e.g., first user        control button 930A) is in its second configuration (e.g.,        spatial position), as shown in FIG. 11B, and    -   second mechanical user control element 320B (e.g., second user        control button 930B) is in its first configuration (e.g.,        spatial position), as shown in FIG. 11A.

For some applications, inflation chamber 335 transitions from a lowerlevel of compression to a higher level of compression during thetransition of second mechanical user control element 320B from its firstconfiguration to its second configuration. For some of theseapplications, input module 156 is configured to elastically biasinflation chamber 335 toward the lower level of compression. For someapplications, inflation chamber 335 (e.g., at least one wall 332 ofinflation chamber 335) is elastically biased toward the lower level ofcompression. For example, the at least one wall of inflation chamber 335may be accordion-shaped and/or the chamber walls comprise an elasticmaterial, such as silicon, rubber, or polyurethane. In some embodiments,substantially no friction needs to be overcome during expansion ofinflation chamber 335. Alternatively or additionally, inflation module330 (such as inflation chamber 335) comprises a distinct elastic element333 (e.g., a spring) that is arranged to bias inflation chamber 335toward the lower level of compression. Alternatively or additionally,second mechanical user control element 320B is elastically biased towardthe lower level of compression (and to the first configuration), forexample by a spring 349. In any event, typically, when second mechanicaluser control element 320B is released, inflation chamber 335 expands. Inother words, input module 156 is biased to assume the firstconfiguration and first fluid-control state when in a resting state,such that inflation chamber 335 is in an expanded state when inputmodule 156 is in the resting state.

For some applications, first mechanical user control element 320Acomprises user control handle 718, the movement of which includes acomponent perpendicular to the associated axial motion of catheter mainbody 210. First mechanical user control element 320A translates themovement of user control handle 718 into axial motion of catheter mainbody 210. For example, first mechanical user control element 320A maycomprise side projection element 730 attached to catheter main body 210,and engaging element 711 that has a diagonal face which engages sideprojection element 730, such that when engaging element 711 moves down,it pushes side projection element 730 sideways and thus imparts axialmotion to catheter main body 210.

Although the fluid-control states of flow regulator 700 of input module156 are sometimes characterized hereinabove as “first,” “second,” and“third,” these ordinal numbers do not necessarily imply a particularorder of activation during use of cleaning system 100 unless explicitlystated. In addition, input module 156 may have activation states inaddition to those described herein, which may be activated before,after, or temporarily between the states described herein. The ordinalnumbers of the states recited in claims do not necessarily correspond tothe ordinal numbers of the states described hereinabove in thespecification.

In the description and claims of the present application, each of theverbs, “comprise,” “include” and “have,” and conjugates thereof, areused to indicate that the object or objects of the verb are notnecessarily a complete listing of members, components, elements or partsof the subject or subjects of the verb. The articles “a” and “an” areused herein to refer to one or to more than one (i.e., to at least one)of the grammatical object of the article. By way of example, “anelement” means one element or more than one element. The term“including” is used herein to mean, and is used interchangeably with,the phrase “including but not limited to.” The term “or” is used hereinto mean, and is used interchangeably with, the term “and/or,” unlesscontext clearly indicates otherwise. The term “such as” is used hereinto mean, and is used interchangeably, with the phrase “such as but notlimited to.”

All publications, patent applications, patents, and other referencesmentioned herein are incorporated by reference in their entirety. Incase of conflict, the present patent specification, includingdefinitions, will prevail. In addition, the materials, methods, andexamples are illustrative only and not intended to be limiting.

For brevity, some explicit combinations of various features are notexplicitly illustrated in the figures and/or described. It is nowdisclosed that any combination of the method or device featuresdisclosed herein can be combined in any manner—including any combinationof features—any combination of features can be included in anyembodiment and/or omitted from any embodiments.

The scope of the present invention includes embodiments described in thefollowing applications, which are assigned to the assignee of thepresent application and are incorporated herein by reference. In anembodiment, techniques and apparatus described in one or more of thefollowing applications are combined with techniques and apparatusdescribed herein. It is noted that the phrase “fluid-control state” usedherein may, for some applications, correspond in some respects to thephrases “mode,” “activation mode,” and/or “operating mode” referred toin the following applications (although many of the configurations ofthese states described herein differ in at least some respects from theconfigurations of the modes described in the following applications). Itis also noted that the phrase “mechanical user control element” usedherein may, for some applications, correspond in some respects to theword “switch,” referred to in the following applications (although manyof the configurations of these states described herein differ in atleast some respects from the configurations of the modes described inthe following applications):

-   -   PCT Publication WO/2012/131626 to Einav et al.    -   GB 2482618 A to Einav et al.;    -   UK Application GB 1119794.4, filed Nov. 16, 2011;    -   U.S. Provisional Application 61/468,990, filed Mar. 29, 2011;    -   U.S. Provisional Application 61/473,790, filed Apr. 10, 2011;    -   U.S. Provisional Application 61/483,699, filed May 8, 2011;    -   U.S. Provisional Application 61/496,019, filed Jun. 12, 2011;    -   U.S. Provisional Application 61/527,658, filed Aug. 26, 2011;    -   U.S. Provisional Application 61/539,998, filed Sep. 28, 2011;    -   U.S. Provisional Application 61/560,385, filed Nov. 16, 2011;    -   U.S. Provisional Application 61/603,340, filed Feb. 26, 2012;    -   U.S. Provisional Application 61/603,344, filed Feb. 26, 2012;    -   U.S. Provisional Application 61/609,763, filed Mar. 12, 2012;    -   U.S. Provisional Application 61/613,408, filed Mar. 20, 2012;    -   U.S. Provisional Application 61/635,360, filed Apr. 19, 2012;    -   U.S. Provisional Application 61/655,801, filed Jun. 5, 2012;    -   U.S. Provisional Application 61/660,832, filed Jun. 18, 2012;    -   U.S. Provisional Application 61/673,744, filed Jul. 20, 2012;    -   PCT Publication WO 2013/030821 to Zachar et al.;    -   U.S. Pat. No. 8,999,074 to Zachar et al;    -   UK Application 1600233.9, filed Jan. 6, 2016;    -   U.S. Provisional Application 62/287,223, filed Jan. 26, 2016;        and    -   U.S. Provisional Application 62/319,640, filed Apr. 7, 2016.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

What is claimed is:
 1. An apparatus for use with a tracheal ventilationtube and a suction source, the apparatus comprising: (A) a cleaningcatheter, which (a) is insertable into the ventilation tube, (b) isshaped so as to define one or more distal suction orifices, and (c)comprises: (i) an elongate, flexible, tubular catheter main body; and(ii) an inflatable element, which is mounted to the catheter main bodyat a location within 3 cm of at least one of the one or more distalsuction orifices; and (B) an input module, which is coupled to thecleaning catheter, and comprises: (i) an inflation module, whichcomprises (a) an inflation chamber separate from the suction source, and(b) a one-way air inlet valve; (ii) a flow regulator, which (a) isshaped so as to define a suction port coupleable in fluid communicationwith the suction source, and (b) is configured to assume at least firstand second fluid-control states; and (iii) a mechanical user controlelement, which is configured (a) to mechanically and non-electricallyset the fluid-control states of the flow regulator, (b) to assume atleast first and second configurations, and (c) to mechanically andnon-electrically increase pressure in an interior of the inflationchamber during at least a portion of a transition of the mechanical usercontrol element from the first configuration to the secondconfiguration, wherein the input module is arranged such that: at leastwhen the mechanical user control element is in the first configuration,the flow regulator is in the first fluid-control state, in which theflow regulator (a) blocks fluid communication between the suction sourceand the distal suction orifices and (b) connects the suction source andan interior of the inflatable element in fluid communication to deflatethe inflatable element, at least when the mechanical user controlelement is in the second configuration, the flow regulator is in thesecond fluid-control state, in which the flow regulator (a) connects thesuction source and the distal suction orifices in fluid communication,(b) connects the interior of the inflation chamber and an interior ofthe inflatable element in fluid communication to inflate the inflatableelement, and (c) does not connect the suction source and the interior ofthe inflatable element in fluid communication, and the flow regulator is(a) not in the first fluid-control state when the mechanical usercontrol element is in the second configuration, and (b) not in thesecond fluid-control state when the mechanical user control element isin the first configuration, wherein the one-way air inlet valve isarranged to allow air to flow into the inflation chamber during at leasta portion of a transition of the mechanical user control element fromthe second configuration to the first configuration.
 2. The apparatusaccording to claim 1, wherein the mechanical user control element isconfigured to mechanically and non-electrically increase the pressure inthe interior of the inflation chamber during an entirety of thetransition of the mechanical user control element from the firstconfiguration to the second configuration.
 3. The apparatus according toclaim 1, wherein the input module is configured such that during the atleast a portion of the transition of the mechanical user control elementfrom the first configuration to the second configuration, before theflow regulator assumes the second fluid-control state, a volume of theinterior of the inflation chamber decreases by between 10% and 90%. 4.The apparatus according to claim 1, wherein the mechanical user controlelement is configured to mechanically and non-electrically increase thepressure in the interior of the inflation chamber during motion of themechanical user control element while the flow regulator is in thesecond fluid-control state.
 5. The apparatus according to claim 1,wherein the suction port is coupled in fluid communication with thesuction source.
 6. The apparatus according to claim 1, wherein the inputmodule further comprises a user signal generator, which is configured togenerate a user signal during or upon deflation of the inflatableelement.
 7. The apparatus according to claim 1, wherein when themechanical user control element is in the second configuration, theinflation chamber has a volume of at least 1 cc less than when themechanical user control element is in the first configuration.
 8. Theapparatus according to claim 1, wherein the mechanical user controlelement is biased toward the first configuration.
 9. The apparatusaccording to claim 1, wherein the cleaning catheter further comprisesone or more suction lumens arranged along the catheter main body, andwherein the flow regulator, when in the second fluid-control state,connects in fluid communication the suction source and the distalsuction orifices via the one or more suction lumens.
 10. The apparatusaccording to claim 1, wherein the inflatable element comprises aballoon.
 11. The apparatus according to claim 1, wherein the apparatusis for use with a ventilator, and wherein the apparatus furthercomprises a tube-connector assembly, which is configured to couple theventilation tube in fluid communication with the ventilator, in asubstantially air-tight connection.
 12. The apparatus according to claim1, wherein the first and the second configurations are first and secondspatial positions, respectively, and wherein the mechanical user controlelement is configured to assume at least the first and the secondspatial positions.
 13. The apparatus according to claim 12, wherein themechanical user control element is arranged to move between first andsecond spatial end-points, and wherein the first and the second spatialpositions correspond with the first and the second spatial end-points,respectively.
 14. The apparatus according to claim 1, wherein the flowregulator is configured to assume a third, intermediate fluid-controlstate, between the first and the second fluid-control states, in which(a) the suction source and the distal suction orifices are in fluidcommunication with one another, and (b) the interior of the inflationchamber and the interior of the inflatable element are not in fluidcommunication with one another, and wherein the flow regulator isconfigured to assume the third, intermediate fluid-control state whenthe mechanical user control element is in a third, intermediateconfiguration between the first configuration and the secondconfiguration.
 15. The apparatus according to claim 1, wherein theone-way air inlet valve is configured to generate a sound signal duringat least a portion of a period of fluid flow into the inflation chamber.16. The apparatus according to claim 1, wherein the mechanical usercontrol element is configured to increase the pressure in the interiorof the inflation chamber by mechanically and non-electricallycompressing the inflation chamber during the at least a portion of thetransition of the mechanical user control element from the firstconfiguration to the second configuration.
 17. The apparatus accordingto claim 16, wherein the inflation chamber transitions from a lowerlevel of compression to a higher level of compression during the atleast a portion of the transition of the mechanical user control elementfrom the first configuration to the second configuration, and whereinthe input module is configured to elastically bias the inflation chambertoward the lower level of compression.
 18. The apparatus according toclaim 17, wherein the inflation module is elastically biased toward thelower level of compression.
 19. The apparatus according to claim 18,wherein the inflation module comprises an elastic element that isarranged to bias the inflation chamber toward the lower level ofcompression.
 20. The apparatus according to claim 17, wherein themechanical user control element is elastically biased toward the lowerlevel of compression.
 21. The apparatus according to claim 1, whereinthe catheter main body comprises a proximal-most input portion, which isdisposed within and axially slidable with respect to the input module.22. The apparatus according to claim 21, wherein the input module isarranged such that changes in configuration of the mechanical usercontrol element cause corresponding changes in axial position of theinput portion of the catheter main body with respect to the inputmodule.
 23. The apparatus according to claim 1, wherein the cathetermain body comprises a proximal-most input portion, which is disposedwithin and fixed with respect to the input module.
 24. The apparatusaccording to claim 23, wherein the mechanical user control elementcomprises a user control handle, wherein the input module is arrangedsuch that the user control handle is moveable with respect to thecatheter main body in two opposite directions along a movement axis thatforms a fixed angle of between 45 and 135 degrees with a centrallongitudinal axis of the proximal-most input portion of the cathetermain body, and wherein the input module is arranged such that movementof the user control handle along the movement axis mechanically causescorresponding movement, along or alongside the movement axis, of adistal opening of the suction port, which selectively brings the distalend of the suction port into and out of fluid communication with theinterior of the inflatable element and the distal suction orifices. 25.The apparatus according to claim 24, wherein the inflation chamber isshaped so as to define an outlet, and wherein the input module isarranged such that movement of the user control handle along themovement axis mechanically causes corresponding movement of the outletof the inflation chamber along or alongside the movement axis, whichselectively brings the interior of the inflation chamber into and out offluid communication with the interior of the inflatable element.
 26. Theapparatus according to claim 1, wherein the inflation chamber isdisposed within the mechanical user control element.
 27. The apparatusaccording to claim 1, wherein the input module comprises exactly onemechanical user control element configured (a) to mechanically andnon-electrically set the fluid-control states of the flow regulator, (b)to assume the at least first and second configurations, and (c) tomechanically and non-electrically increase the pressure in the interiorof the inflation chamber during the at least a portion of the transitionof the mechanical user control element from the first configuration tothe second configuration.